Euro Roundup: Britain proposes postmarket surveillance law in first major update to medtech regulations

According to the Medicines and Healthcare Products Regulatory Agency (MHRA), proposed legislation to provide “more stringent and clearer” postmarket surveillance (PMS) requirements is the first major update to the framework of medical device regulations in Great Britain.

MHRA prepared the statutory instrument based in part on recommendations set out in the Independent Medicines and Medical Devices Safety review in 2020 and feedback on the future of medtech regulation the following year. The agency said the consultation strongly supported introducing more transparent and robust PMS rules to improve patient safety and align with international approaches.

Parliament is set to debate a draft statutory instrument to achieve those goals. In an explanatory note published alongside the draft, officials said the proposals extend the scope of the requirements to CE-marked devices. Under the post-Brexit transition arrangements, companies can place the devices, which constitute 91% of products registered with MHRA, on the market in Great Britain.

Extending the law's scope to cover devices with CE marks will ensure parity between those products and technologies cleared under the UKCA scheme. However, CE-marked devices will not be subject to the requirement that manufacturers ensure postmarket data are used to update technical documentation. The instrument cannot require manufacturers to update documentation set out in EU law.

Other changes would require manufacturers to maintain a PMS system for all devices sold in Great Britain. The system should enable the analysis of data relevant to the quality, performance, and safety of the device throughout its lifetime and record the conclusions the manufacturer reached. PMS systems must also capture data on similar devices available in the UK and overseas.

“This requirement is intended to ensure that the MHRA captures a better picture of how devices are performing outside of the GB market,” officials said. “The regulations will require manufacturers to carry out preventive and corrective actions. The regulations will also include requirements around notification and monitoring of preventive and corrective actions.”

MHRA said the requirements address the current lack of PMS provisions. The gap in the current regulatory requirements “creates inconsistencies that impact MHRA data quality and makes recognising safety issues difficult,” the agency said. MHRA estimates the net cost of the new requirements to businesses will be £35.9 million ($46.4 million) a year.

“Small and micro-sized enterprises [SMEs] are estimated to incur 15%-25% of the costs to business,” officials said. “Given that one objective of these measures is to ensure a consistent level of stricter safety standards across medical device suppliers, the decision was made not to exempt SMEs.”

Press Release, Statutory Instrument, More

EMA publishes interim report on pilot use of clinical study data in medicine evaluation

The European Medicines Agency (EMA) has published a report about the first five participants in a pilot project to evaluate the benefits of using clinical study data in medicinal product scientific assessments.

Under reforms proposed by the European Commission, drug developers would submit clinical study data in a manipulable format when they file initial marketing authorization applications. Currently, companies send data aggregated as clinical summaries or individual patient data in PDF listings.

The interim report covers the experience EMA and pilot participants gained through December 2023. According to a survey, most participants (83%) reported added value from access to clinical study data at the time of submission in at least one area. The areas include an improved understanding of product dossiers, shorter lists of questions to applicants, and a greater consensus on methodological issues among regulators. The survey also found that 93% of respondents said the data could improve good clinical practice site inspections.

The report also noted that there is “no evidence to suggest that assessment was impaired by the need to conduct additional tasks on clinical study data, be it access to or analysis of clinical study data.”

EMA has extended the pilot and continues to accept expressions of interest. The agency said the extension “will allow for inclusion of additional regulatory procedures, possibly beyond the initially targeted number of 10 applications in the pilot’s second phase,” and focus on addressing knowledge gaps and validating the benefits seen to date.

Interim Report

Point-of-care drug production regulation put before UK Parliament

The UK has proposed a regulatory framework for innovative products manufactured at or near the point of patient care.

In a note explaining the planned legislation, UK officials said it would be highly challenging to regulate medications that need to be produced close to the point of patient care because the current system “does not allow for these types of manufacturing processes.”

The UK aims to be the first country to create a tailored framework for these processes. The new framework uses a hub-and-spoke model. One control site serves as the hub for each product and oversees all aspects of the point-of-care system. The control site is the only production site named on the manufacturing license.

“Products may be manufactured at multiple sites across the country. Rather than having to name all of those sites in the manufacturing license and marketing authorization, and make amendments as sites are added or removed, the control site will be named and the manufacturing sites recorded in a separate master file, which can be updated as sites change,” UK officials said.

Press Release, Statutory Instrument

MDCG makes substantial changes to guidance on MDR requirements for legacy devices

The Medical Device Coordination Group (MDCG) has updated its guidance on applying Medical Device Regulation (MDR) requirements to legacy devices.

The update aligns the guidance with the general structure of MDCG documents and adapts the text in light of extending the transitional periods of the medtech regulations.

The group highlighted substantial changes to several sections of the document. MDCG has clarified that Article 19 of MDR, which covers the EU declaration of conformity, does not apply to legacy devices. Other changes include clarifying the application of the transitional provisions to systems and procedure packs and the need to establish a quality management system.

MDCG Guidance

Other news:

The European Economic Area’s global share of clinical trials has halved over the past decade, according to a report by EFPIA. The industry group found the area accounted for 22% of pharma-sponsored trials in 2013. The figure fell to 18% in 2018 and 12% in 2023. EFPIA said the region’s “less favorable” regulatory environment has contributed to its falling share of clinical trials. EFPIA Statement

Euro Roundup: Britain proposes postmarket surveillance law in first major update to medtech regulations

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